The present invention relates to a method for the production of medicinal compositions, in particular to a method for the production of ispaghula-containing compositions wherein the ispaghula is sanitised and optimised for inclusion in ingestible compositions. Ispaghula is obtained from the plant species Plantago ovata. Ispaghula is sometimes referred to as psyllium.
Ingestible ispaghula-containing compositions for the relief of gastric and digestive dysfunctions are known. The efficacy of ispaghula for the relief of such dysfunctions, including constipation, is well recognised and commercial formulations are readily available. Examples of such compositions include particulate ispaghula intended to be stirred in measured amount into a volume of liquid, usually water or a soft drink. After stirring, the drinking composition is intended to be quickly imbibed due to the propensity of the ispaghula to absorb water readily and swell to form a viscous gel-like mass. It is the property of water absorption which is the desired characteristic of ispaghula in compositions for gastric and digestive dysfunctions. Once the ispaghula has absorbed water to produce the gel-like mass, the mass is relatively insoluble and fibrous, and is transported through the gut quickly with minimal digestion, helping to alleviate constipation and the like.
Other forms, such as tablet forms for ingestion, are also available, such tablets being designed to be broken down in the gut, wherein the released ispaghula absorbs water from the gut to form the viscous mass.
It is usual for the ispaghula in such compositions to comprise the seed husks or hulls of the ispaghula plant. The seeds, including the husks, are usually harvested from the plant, then dried, then subjected to a mechanical treatment, to separate the seed kernels from the husks. The broken husks then generally make up over 50% by weight of the ispaghula portion of the ingestible composition, with the remaining ispaghula portion predominantly being the seed kernels themselves. In many methods the seed kernels are removed, because they are less palatable than the husks. The ispaghula can be processed, following removal of the seeds if wished, by grinding, flaking or other known operations but may be used without any further processing.
As the ispaghula used in such compositions is a natural product obtained from plants, purity is of great concern. As the ispaghula compositions are to be imbibed or otherwise consumed, it is desired that the ispaghula is sanitised to kill off any foreign biological matter such as insects and microorganisms entrapped within the ispaghula material.
Various methods have been proposed to sanitise the ispaghula, including raising the ispaghula to elevated temperatures to provide a heat sterilising effect, and contacting the ispaghula with steam to provide a stream sterilising or “autoclaving” effect. Although both forms of sanitising provide effective sterilising effects there are some associated problems, such as swelling of the ispaghula due to absorption of water during the sterilisation process. This renders the ispaghula sterilised by these processes difficult to formulate into granules, powders or tablets.
As mentioned hereinbefore, one of the most desirable characteristics of ispaghula when used in the relief of gastric and digestive dysfunctions is its ability to absorb water in the gut and form a viscous, fibrous mass which is quickly transported through the gut without absorption from it.
Thus from the foregoing it is apparent that there is a need for the provision of a process for treating ispaghula which renders the ispaghula safe for human consumption whilst not introducing absorbed water to the ispaghula during the process, the process also maintaining or improving the capability of the ispaghula to absorb water in the gut after ingestion.
It is therefore an object of preferred embodiments of the present invention to overcome or mitigate the shortcomings of the known processes described above.